Patent application title: Universal medical device control console

Abstract:

A control consol is disclosed for controlling one or more medical devices.
The control consol communicates to at least one medical device, and at
least one peripheral module associated with the medical device if needed.
The control consol has a microprocessor for processing data to direct an
operation of the medical device.

Claims:

1. A control consol for controlling a variety of electrically powered
medical devices comprising:at least one device connecting module
configured to communicate with at least one medical device; anda
microprocessor based control module for directing an operation of the
medical device based on communications from the medical device.

2. The control consol of claim 1 wherein the medical device is a handheld
medical device.

3. The control consol of claim 1 wherein the medical device is a surgical
device.

4. The control consol of claim 1 wherein the medical device is a computer
controlled device.

5. The control consol of claim 4 wherein the computer controlled medical
device is wirelessly controlled.

6. The control consol of claim 1 wherein the medical device includes at
least one radio frequency or mechanically energized tool for performing
surgical or medical operations.

7. The control consol of claim 1 wherein the medical device is a biopsy
probe.

8. The control consol of claim 1 wherein the medical device is a
temperature probe.

9. The control consol of claim 1 wherein the medical device is a heart
rate monitor device.

10. The control consol of claim 1 wherein the medical device is a drug
infusion tool.

11. The control consol of claim 1 wherein the medical device is an
anesthesia tool.

12. The control consol of claim 1 further comprising at least one
peripheral module connector for connecting to at least one peripheral
module associated with the medical device.

13. The control consol of claim 12 wherein the peripheral module is
controlled by the medical device.

14. The control consol of claim 12 wherein the peripheral module is an
electro surgical generation module.

15. The control consol of claim 12 wherein the peripheral module is a
footswitch module.

16. The control consol of claim 12 wherein the peripheral module is a
vacuum pump module.

17. The control consol of claim 12 wherein the peripheral module is a
fluid pump module.

18. The control consol of claim 1 further comprising a software module for
controlling logical and interface functions.

19. The control consol of claim 18 wherein the software module further
generates control signals.

20. The control consol of claim 18 wherein the software module further
receives and processes a predetermined software script from the medical
device for operating the same.

21. The control consol of claim 1 wherein the operator module further
includes one or more switches and indicators.

22. The control consol of claim 1 wherein the switches and indicators are
selectively activated when one or more predetermined display screens are
presented.

23. The control consol of claim 1 further comprising a power module.

24. The control consol of claim 1 wherein the connecting module is a
connector for connecting and communicating with the medical device.

25. The control consol of claim 1 wherein the connecting module
communicates with the medical device wirelessly.

26. The control consol of claim 1 further comprising an analog-to-digital
converter for receiving analog inputs.

27. The control consol of claim 1 where in the medical device operates
with an illumination device powered by the control consol.

28-36. (canceled)

37. The control system of claim 53 wherein the control module controls the
operation of the medical device through one or more operation switches
and one or more graphical display screens, wherein the operation switches
are selectively activated when one or more predetermined graphical
display screens are presented.

38. The control system of claim 53 wherein the medical device is a biopsy
probe.

39. The control system of claim 53 wherein the medical device is a
temperature probe.

40. The control system of claim 53 wherein the medical device is a heart
rate monitor device.

41. The control system of claim 53 wherein at least one of the peripheral
modules is an electro surgical generation module.

42. The control system of claim 53 wherein at least one of the peripheral
modules is a footswitch module.

43. The control system of claim 53 wherein at least one of the peripheral
modules includes a fluid pump module.

44. The control system of claim 53 wherein at least one of the peripheral
modules is an illumination device.

45. The control system of claim 53 further comprising a software module
for controlling logical and interface functions of the operation.

46. The control system of claim 45 wherein the software module further
receives and processes a predetermined software script from the medical
device for operating the same.

47. The control system of claim 53 wherein the graphical display further
includes one or more operating indicators.

48. The control system of claim 53 wherein one of the peripheral modules
comprising a power module.

49. The control system of claim 53 wherein the control module controls the
operation of the medical device through wireless communication links.

50. The control system of claim 53 wherein the control module controls the
operation of the medical device through wired communication connections.

51. The control system of claim 53 wherein the control module controls the
operation of the medical device through digital signals.

52. The control system of claim 53 wherein the control module controls the
operation of the medical device through analog signals.

53. A control system for controlling a predetermined plurality of
different types of medical devices, each of which have their own stored
scripts for operating functions of the devices, comprising:a. a universal
control console having one or more connecting modules configured for
communicating with and receiving the predetermined plurality of different
types of medical devices having stored scripts for operating functions of
the devices;b. a plurality of peripheral modules which communicate with
one or more of the connecting modules and which control operating
functions of the different types of medical devices and are responsive to
the stored operating scripts of the medical device connected to the
connecting module; andc. a microprocessor based control module in
communication with the connecting modules and the plurality of peripheral
modules which communicate therewith for controlling operation of the one
of the different types of medical devices connected to the connecting
module in accordance with the operating script thereof.

54. The control system of claim 53 wherein the medical device has
operating scripts for at least one of the vacuum generation,
electrosurgical power and motor drive control.

55. The control system of claim 54 wherein the medical device has
operating scripts for one or more peripheral modules configured for
communicating with other modules.

56. The control system of claim 53, wherein the control console has a
control module that controls the operation of the medical devices through
one or more operation switches.

57. The control system of claim 53, wherein one of the peripheral modules
controlling electrosurgical generation includes a high frequency power
generator.

[0002]The present invention relates generally to medical devices, and more
particularly to a universal control consol for operating with a variety
of medical devices. Still more particularly, the present disclosure
relates to the design of a universal medical equipment control consol
that interfaces with a variety of handheld medical instruments, and the
method to control the same.

[0003]Conventional medical equipment design typically requires separate,
dedicated hardware and software control modules for each handheld medical
device. Each of these devices requires a graphical display,
microprocessor, interface circuitry and software to operate the medical
device, and to provide the operator with pertinent status/action
information. An "operator" is defined as any medical personnel capable of
operating the medical device. The operator may be a nurse, a medical
doctor, or a medical assistant.

[0004]The graphical user interface (GUI) will vary from device to device,
thereby resulting in additional cost for operator training, proficiency,
and certification. As the number of dedicated control modules increases,
surgical and storage spaces must necessarily increase, as must the
complexity of inventory logistics.

[0005]What is needed is a universal control consol that can control a
variety of medical devices, thereby eliminating the need for separate,
dedicated control hardware for each medical device.

SUMMARY

[0006]In view of the foregoing, a universal medical equipment control
consol is provided that interfaces with a variety of medical devices.

[0007]This disclosure will provide a detailed description of how a medical
device interacts with the universal medical equipment control consol.
Additional medical devices may be implemented. This concept allows for a
universal control consol with all the necessary hardware interface
modules and software modules that can control a variety of medical
devices, thereby eliminating the need for separate, dedicated control
hardware for each medical device.

[0008]This universal control consol will provide a graphical user
interface (GUI) for all devices that would decrease the need for operator
training and certification requirements while increasing the simplicity
of operation. Additional benefits include reduced surgical space, storage
space, and inventory logistics costs. Some advanced models of the
universal control consol may have the ability to handle multiple devices
simultaneously.

[0009]In one example, a control consol is disclosed for controlling one or
more medical devices. The control consol communicates to at least one
medical device and, if needed, at least one peripheral device module
associated with the medical device. The control consol is microprocessor
based for directing an operation of the connected medical device.

[0010]The construction and method of operation of the invention, however,
together with additional objects and advantages thereof will be best
understood from the following description of specific embodiments when
read in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011]FIG. 1A is a schematic diagram illustrating a universal control
consol which embodies features of the invention operating with a
plurality of medical devices.

[0012]FIG. 1B is a schematic diagram illustrating a universal control
consol which embodies features of the invention operating with a
plurality of medical devices and peripheral modules through a housing
module.

[0013]FIG. 2 illustrates the major components of the universal control
consol shown in FIG. 1A or 1B.

[0014]FIG. 3 illustrates a frontal view of the universal control consol
shown in FIG. 1A embodying features of the invention.

[0015]FIG. 4 illustrates a rear view of the universal control consol shown
in FIG. 1A embodying features of the invention.

[0016]FIG. 5 presents a flowchart illustrating the relationship between
various Graphical User Interface (GUI) display screens embodying features
of the invention.

[0017]FIG. 6 represents various display screens for the universal control
consol embodying features of the invention.

[0018]FIG. 7 illustrates a flowchart illustrating an interactivity between
various software components of the universal control consol embodying
features of the invention.

[0019]FIG. 8 illustrates a design embodying the interaction between a
biopsy device and the universal control consol.

[0021]FIG. 10A presents a flowchart illustrating the operating states of
the universal control consol with the biopsy device in accordance with
one example of the present invention.

[0022]FIGS. 10B to 10D present various display screens in relation to the
states in FIG. 10A in accordance with one example of the present
invention.

[0023]FIGS. 11A and 11B represent a probe failure processing flowchart and
its corresponding display screen in accordance with one example of the
present invention.

[0024]FIG. 12 present the display screens in the tool error state in
accordance with one example of the present invention.

[0025]FIGS. 13A and 13B present a ESG failure processing flowchart and its
corresponding display screens in accordance with one example of the
present invention.

[0026]FIGS. 14A and 14B present a vacuum failure processing flowchart and
its corresponding display screens in accordance with one example of the
present invention.

[0027]FIGS. 15A and 15B present a tool exit processing flowchart and its
corresponding display screens in accordance with one example of the
present disclosure.

DESCRIPTION

[0028]FIG. 1A presents a diagram 100 illustrating the relationship between
the universal control consol 102 and a plurality of medical devices 104,
106 or 108 in accordance with one example of the present disclosure.
Devices 104, 106 and 108 represent some of the many individual medical
devices that may connect or communicate to the universal control consol
102 via a connector 110 or via wireless communication links. Many of the
medical devices are controllable by a computer based operating tool so
that the universal control consol can communicate and control the medical
device in many ways without human interaction. In the following
illustration, wherever it is said that a device or module is connected to
another device or module, it is understood that the term "connected" may
also mean that they can be connected wirelessly without physically
connected through wires. In most of the time, at least one device will be
connected to and operational with the universal control consol 102. The
universal control consol 102 may also have a bypass mode in which a
medical device may not be connected. The universal control consol 102 may
interface with and control the functions of any one of the devices 104,
106 and 108 via the connector 110.

[0029]In one embodiment, each of the devices 104, 106, and 108 may
represent a biopsy probe, temperature probe, heart rate monitor device,
drug infusion tools, anesthesia tools, or other surgical or medical
device that may operate with the universal control consol 102. These
devices may serve various surgical or non-surgical functions such as
separating specimen from tissue bed, encapsulating the separated
specimen, insulating a cutter from body, fixing one end of a cutter while
moving another end thereof. These devices may be made by or operated with
products of SenoRx of Aliso Viejo, Calif. such as the SenoCor Biopsy
Device and the EnCor Biopsy Device. The surgical devices may be energized
mechanically or through radio frequency (RF) energy for performing the
surgery. For instance, a RF surgical tool uses RF energy to remove
unwanted body parts while the same function may be achieved by a
mechanical tool such as a blade. Each of these medical devices may
require a unique set 112 of peripheral modules 114, 116 and 118, which
are connectable to and controlled by the universal control consol 102 via
connectors 120, 122 and 124, respectively. As an example, the device 104
may be a biopsy probe, which in turn may require a plurality of
peripheral modules 114, 116 and 118, which further in turn may be an
electro surgical generation (ESG) module, an illumination device, a
footswitch module, and a vacuum/fluid pump module. It is understood that
peripheral modules provides additional features or functions for the
operation of the medical device, and can be of different forms and
functions, and they may not be required to be physically connected to the
universal control consol as long as they can communicate therewith. In
some cases, the peripheral devices are controlled by the medical device
through the universal control consol.

[0030]The universal control consol 102 is a microprocessor-based
electrical device with built-in software functions necessary to operate
various medical devices. Each medical device contains a software script,
stored in a memory device within the medical device for operating that
particular device when connected to the universal control consol 102. For
example, the said software script may be stored in non-volatile memories
such as erasable programmable read only memories (EPROMs), electrically
erasable programmable read only memories (EEPROMs) or flash memories.
When a medical device is connected to the universal control consol 102,
this software script will be downloaded into the universal control consol
random access memory (RAM). This software script will enable the
universal control consol 102 to control the functionalities of the
particular medical device and to display its pertinent information.
During the operation of a medical device, the Graphical User Interface
(GUI) software will display information relevant to the operation of the
universal control consol 102 and the medical device to the operator. It
is understood by those skilled in the art that the information displayed
may vary depending upon the type of medical device connected, the
operational state of the medical device as well as other environmental
factors affecting the operation of both the medical device and the
universal control consol 102.

[0031]It is understood that although traditionally the medical devices are
connected to the universal control consol 102 through wired connections
(including connectors and wires) or battery powered for their operations,
the control of the medical devices by the universal control consol 102
can be easily implemented through wireless communications. Needless to
say, certain peripheral devices may have to be physically connected to
the medical device to deliver fluid or assert vacuum. The conventional
wired connections have certain advantages such as low signal
interferences, but the wireless technology can turn the operation of the
medical device to mobile operation, which benefits the operator as well.
For example, other than the power output provided by the universal
control consol 102, almost all the control signals can be sent through a
predetermined wireless communication channel using technologies such as
Bluetooth or 802.11 compliant wireless technologies. When the medical
device is battery powered, then the operation may be all mobile. It is
also practical that the wired communication channels may be used together
with the wireless communication channels so that the universal control
consol can take advantage of the available wireless technologies for
providing convenience to the operator, while still benefiting from using
some conventional wired technologies. Similarly, analog signals used in
the communications can be replaced by digital signals if appropriate
since the digital signal processing technology has also advanced. In
short, while the present disclosure only provides some examples for
illustrating the inventions, it should be understood that communications
between devices can take various forms and the universal control consol
102 is designed to use the most practical technologies for fulfilling the
need of the operators.

[0032]A housing module may also be provided to house, and to supply
electrical power to, some of the aforesaid modules and equipments. An
example is provided in FIG. 1B, which is a schematic diagram 126
illustrating the relationship among a housing module 128, the universal
control module 102 and the unique set 112 of peripheral modules 114, 116
and 118. The housing module 128 includes a power strip 130, which
connects, via a power cord 132, to an electrical power source, such as a
220-240V AC power source. The power strip 130 is utilized to distribute
electrical power to a plurality of modules and equipments. A line cord
134 may be utilized to deliver electrical power from the power strip 130
to the universal control module 102. A plurality of line cords 136, 138
and 140 may also be utilized to deliver electrical power from the power
strip 130 to the peripheral modules 114, 116 and 118, respectively. It is
understood that the housing module 128 may provide docking stations (not
shown) for the handheld medical devices 104, 106 and 108. It is further
understood that the housing module 128 can be a cart or a portable
cabinet; that the power strip 130 and the aforesaid modules are
fixed-mounted or screw-mounted onto the housing module 128; that the
housing module 128 includes a plurality of moving wheels and accessible
handles; and that the housing module 128 includes a wire latch that
organizes and secures a plurality of line cords and data cables.
Essentially, the housing module 128 functions as an organizer, a power
distributor and an ergonomic solution for the operator to access the
plurality of modules and equipments.

[0033]FIG. 2 illustrates several components of the universal control
consol 102. The universal control consol 102 includes a graphics module
202, a microprocessor module 204, a software module 206, a hardware
interface module 208, an operator module 210 and a power module 212.

[0034]The graphics module 202 may include a cathode ray tube (CRT)
display, a liquid crystal display (LCD) or any other type of display that
may be used to display information relevant to the operation of the
universal control consol 102 and medical devices. The graphics module 202
may also require a piece of Graphical User Interface (GUI) software that
is used to display all pertinent information to the operator.

[0035]The microprocessor module 204 may include microprocessors,
motherboard circuitries, memories and other functional electronic devices
that enable the universal control consol 102, the operator controls
thereof, the functions of medical device, and the functions of peripheral
modules. It may also interface with an external computer via an external
computer interface connector for system troubleshooting, software
upgrade, and other shop functions.

[0036]The software module 206 controls the logical and interface functions
of the universal control consol 102, the logical and interface functions
of the medical devices attached thereto, the logical and interface
functions of the peripheral modules attached thereto, and the operator
control switches therein. The software module 206 may also generate
various control signals such as audible tones (for example, sounds of
Bong, Click, and Alarm) that are applied to a speaker located within the
universal control consol 102. The Bong and Click tones may be adjustable
by a predetermined setting. Depending on software specification, the
alarm tone may or may not be adjustable. As an example, the software may
be written in "C" code, although it is understood by those skilled in the
art that various other software languages may be used to write the
software for the universal control consol 102. Specifically, the software
module 206 may include any combination of the following: core software
operating the universal control consol 102, GUI software for presenting
graphics in the graphics module 202, built-in self-test (BIST) software,
and software for controlling and interfacing with medical devices and
peripheral modules. Each medical device, when connected to the universal
control consol 102, may download a software script. This software script
will allow for the control of the particular medical device functions and
display its pertinent information.

[0037]The hardware interface module 208 may include circuitries and
connecting modules necessary to allow medical devices or peripheral
modules to be connected to the universal control consol 102. These
connecting modules may be general connectors compliant with various
well-known standards, including but not limited to Institute of
Electrical and Electronics Engineers (IEEE) standards and International
Organization of Standardization (ISO) standards. These connectors may
also be proprietary connectors specific to a particular medical device or
peripheral modules, or a particular line of medical devices or peripheral
modules. In addition, the connecting modules may be a circuitry for
communicating wirelessly with a device controlled by the universal
control consol.

[0038]For example, the hardware interface module 208 may have a computer
interface connector. The computer interface connector is used for system
troubleshooting, software upgrades, and other shop functions. This
connector contains connectors for RS-232 communication, connectors for
background debug mode (BDM), and connectors for other shop activities. In
another example, the hardware interface module 208 may have an AC power
input connector, which may be a three-wire connector connectable to
100-120 VAC and/or 220-240 VAC, at 50-60 Hz. In yet another example, the
hardware interface module 208 may have an AC power output connector,
which is connectable to other peripheral equipments and which provides
the other equipments with AC power. In yet another example, the hardware
interface module 208 may have a DC power output connector, which is
connectable to other peripheral equipments and which provides the other
equipments with DC power. It is understood that either DC or AC power can
be delivered to an illumination device such as a light bulb or any
surgical lighting device attached to or integrated with a medical device
such as a biopsy probe used with the control consol. The control consol
may provide further remote operation control for the illumination device.

[0039]Other hardware interface circuitry and connectors implemented into
the universal control consol 102 may depend upon the medical devices and
its associated peripheral equipment that have been certified to operate
with the universal control consol 102. As additional medical devices are
selected, upgrades to the hardware and software may be required. Since
analog and digital signals may co-exist in various operations, the
universal control consol may have analog-to-digital (A/D) converters or
even digital-to-analog (D/A) converters contained therein for processing
various signals coming in or going out from the universal control consol.

[0040]Referring back to the previous embodying example, the biopsy probe
may require an ESG module, a footswitch module, and a vacuum pump module.
The biopsy probe and its associated peripheral modules in turn may
require the following interface connectors: a medical device connector,
an ESG connector, a footswitch connector, and a vacuum pump connector.

[0041]The medical device connector may contain a plurality of copper wires
for bi-directional digital communications, EEPROM communication, encoder
functions, light emitting diode (LED) & relay control, motor control,
power, and ground. The ESG connector may provide bi-directional
communication for the control and status of the ESG module and the
universal control consol 102, and may include a RS-485 data bus for
status communication. The footswitch connector may pass information from
the footswitch module to the universal control consol 102, thereby
allowing the operator to control the ESG module and the universal control
consol 102 by the tapping of the foot. Finally, the vacuum pump connector
may provide data and control information between the vacuum system and
universal control consol 102. It may contain system data and clock lines,
vacuum level and control lines, and status lines.

[0042]The operator module 210 may include various pushbutton switches and
indicators that assist the operator to operate the universal control
consol 102. For example, there may be, adjacent to the display screen,
three operator pushbutton switches that are under software control. The
function of the switches may be dependent upon the display screen at a
particular instance. The display screen displays the required actions and
what action may be activated with a particular switch at a given
instance.

[0043]To further illustrate how the operator module 210 assists the
operator, the operator module 210 may have two indicator lights, one of
which is an orange standby indicator light on the front panel that may be
activated when the rear mounted power switch is depressed and the system
enters a standby state, while the other of which is a green indicator
light on the front panel that may be activated when a front mounted power
switch is depressed for a minimum of 2 seconds, thereby signaling the
universal control consol 102 to kick-start its boot up sequence. When the
front mounted power switch is depressed again for a minimum of 2 seconds,
the display may indicate that the universal control consol 102 is in the
process of shutting down. During an orderly shutdown, the universal
control consol 102 may complete any actions required by the medical
device, save any required settings, and then return to the standby mode.

[0044]The power module 212 may include a transformer, AC power input and
output connectors, a power system, fuse, and a power switch. The power
module 212 may supply power to the rest of the universal control consol
102, and may supply power to other peripheral modules and medical devices
attached thereto.

[0045]FIG. 3 illustrates a frontal and top view 300 of the universal
control consol 102 embodying features of the present invention. The front
of the case enclosure 302 includes a graphical display screen 304,
various operator control switches 306, a medical device connector 308, a
front power switch 310, an orange "standby" indicator light 312, and the
green "on" light 314. It is understood that the connector 308 is an
example for a connecting module which either physically connects to a
device or wirelessly communicates to a device without any physical
connection existing therebetween.

[0046]FIG. 4 illustrates a rear and bottom view 400 of the universal
control consol 102 shown in FIG. 3. The rear of the case enclosure 402
includes a power module 404, a footswitch connector 406, a vacuum
connector 408, an ESG connector 410, spare connectors 412 for future
medical device/peripheral equipment additions, and the external computer
interface connector 414 behind the removable panel 416. The power module
404 includes the input power connector 418, output power connector 420,
AC power fuse 422, and the rear power switch 424. The bottom of the
enclosure 402 includes the alarm speaker 426 for the Bong, Click, and
Alarm tones.

[0047]FIG. 5 presents a flowchart 500 illustrating the relationship
between various display screens, which are referred to and shown in FIG.
6, in accordance with one example of the present disclosure.

[0048]In particular, the flowchart 500 illustrates the software flowchart
covering the initial boot-up, medical device connection, utility mode
setup, boot-up alarm sequence and the downloading of the medical device
script. A general high-level software flow 502 illustrates how the
software module generally handles any medical device that is connected to
the universal control consol 102. This software flow may be unique for
each medical device operation.

[0049]The flowchart 500 begins at a boot-up process 504 that occurs when
the power-on sequence is started. In decision box 506, the universal
control consol 102 checks the shop mode jumper to determine if the system
should go into the shop mode for troubleshooting/ upgrade, as illustrated
by box 508, or continue the normal boot-up process. A decision box 510
determines whether a language selection screen should be displayed to the
operator to select the desired operator language. If the language
selection screen should be displayed, a language screen, which may look
like the screen 602, may be displayed. This selection is accomplished
through the use of the pushbutton switches located adjacent to the
graphical display screen. The universal control consol software script
controls the functions of these switches. Once the desired language is
selected, a boot-up splash screen that may look like the screen 604 is
displayed.

[0050]If the medical device has been connected, the script will go
directly to download the medical device script, and a screen that may
look like the screen 606 is displayed to the operator. If an alarm is
generated during the boot-up process, the script will transfer to the
boot-up alarm screen 608 to ask the operator to reset the system. If no
medical device has been connected, a bypass mode screen that may look
like the screen 610 may be displayed, wherein the operator is asked to
connect the medical device or to access the utility menu. If the operator
connects the medical device, then the script goes directly to the device
script download mode and the screen 606 may be displayed. If the operator
wishes to enter the utility mode, then the operator depresses the
"SELECT" pushbutton switch, thereby switching to the utility screen,
which may look like the screen 612. The utility menu allows the operator
to adjust the volume level, which may be accomplished in a volume level
screen that may look like the screen 614, to adjust the display screen
intensity level, which may be accomplished in a display screen intensity
level screen that may look like the screen 616, or to go back to the
screen 610 such that the operator may connect the medical device. Once
the correct volume or display screen intensity is selected, the operator
is transferred back to the bypass mode screen. When the medical device is
connected to the universal control consol 102, the script goes directly
to the device script download mode and screen 606 may be displayed. Once
the script is downloaded, the downloaded script controls the universal
control consol 102 and its display as determined by the type of medical
device connected. In flow 502, the connected medical device determines
the system operation and display screens. One example of the system
operation and display screens in flow 502 are presented, in detail, in
FIGS. 10 to 17. Through this flow, the appropriate control configuration
of a medical device is managed by the universal control consol 102. For
example, it detects and configures itself to match the operating
configuration of the medical device. For example, it detects and provides
an appropriate voltage supply for operating the medical device. It may
also provide control signals to control the motor in the medical device.
It may provide appropriate GUI windows to the operator with regard to the
medical device so that the operator only needs to deal with relevant GUI
windows for operating the medical device. If a vacuum pump is needed to
be used in conjunction with the medical device, it not only will indicate
to the operator whether a vacuum pump is properly connected, it will also
provide the appropriate operating voltage to the vacuum pump. In short,
the universal control consol 102 is to assist the operator to operate
multiple medical devices with ease. To the extent possible, all
configurable items for operating the medical device are either
automatically provided to the device or prompted to the operator to be
chosen so that they can be then provided to the connected device.

[0051]The three pushbutton switches are utilized in the displays that
require an operator action, such as language selection, volume adjust,
reset, etc. It is understood by those skilled in the art that all display
screens in FIG. 6 are presented to illustrate the spirit of the
invention, are subject to change, and are not considered to be the only
version.

[0052]FIG. 7 presents a flowchart 700 illustrating the high level
interactivity between various software components of the universal
control consol 102 in accordance with one example of the present
disclosure. The components include a main module 702, a tool-code module
704, an application program interface (API) module 706, a core software
module 708 that in turn includes a self-test module 710 and a GUI module
712, a control software module 714 that in turn includes a communication
control module 716, a vacuum pump control module 718 and a motor control
module 720, a RF control module 721, and a binary I/O module 722.

[0053]The main module 702 contains software functions for the operation.
For example, it includes a reset function in assembly code that is
required to start the controller and run a portion of the self-test. The
main module 702 also includes a high-level code that runs the main loop
and performs some additional self-tests, including memory and processor
tests.

[0054]The tool-code module 704 loads the tool code from nonvolatile
memories into the code buffer of the volatile memories and then runs
tests thereon. The tool code may be tested by a variety of methods. For
example, one tool code testing method is by using cyclic redundancy check
(CRC). The tool-code module 704 may also allow the universal control
consol 102 to write to nonvolatile memories.

[0055]Another functionality of the tool-code module 704 may include the
testing of nonvolatile memories. In other words, the tool-code module 704
may run periodic tests to ensure that nonvolatile memories are not
corrupted.

[0056]The API module 706 may include an API called by the tool code, and
an API manager that is used to manage the said API. The API is used by
the tool-code module 704 to request the universal control consol 102 to
act in a certain manner. As an example, one implementation strategy may
call for the use of software interrupts to request certain API routines,
via the API module 706.

[0057]The self-test module 710 may include built-in, self-test (BIST)
software that is used to perform various self-testing operations. Most of
these self-testing operations should be non-invasive, i.e., they should
test for mis-configuration, but should not actively induce one.

[0058]The GUI module 712 may include software that is used to draw outputs
to the screen. This GUI module 712 may also include functions such as the
initialization of the color palette upon boot-up, the drawing of the
first splash display screen, and the refreshing of subsequent display
screens.

[0059]The communication control module 716 may include software that
controls the inputs and outputs through the RS-485 connector. The
communication control module 716 keeps all information about a port in a
table, which is typically indexed to ensure fast referencing. The
interrupt callback routines of the communication control module 716 may
be passed to a hardware access layer, thereby enabling the universal
control consol 102 to receive incoming data.

[0060]The vacuum pump control module 718 may include software that
controls the vacuum pump system interface. For example, the vacuum pump
control module 718 may be able to detect vacuum and pump power. It may
also be able to translate commands sent by the universal control consol
102 to actual pressure, and vice versa.

[0061]The motor control module 720 may include software that controls the
motors located in the medical device. The motor control module 720 may
provide the universal control consol 102 with various operating modes.
For example, the motor control module 720 may provide a
feedback-controlled operating mode, which may employ a variety of
discrete proportional-integral-derivative (PID) feedback algorithms to
provide feedback functionality. The motor control module 720 may also
provide various constant operating modes, including constant current and
constant voltage operating modes, which may be necessary for medical
devices that require a steady motor. The RF control module 721 is
dedicated to control devices using RF energy.

[0062]The binary I/O module 722 may include software that performs the
binary input and output. For example, the binary I/O module 722 maps an
array of binary outputs to its corresponding array of hardware address
registers, and writes data flags to the latter. For example, when the
"power-off" button is pressed, the binary I/O module 722 first searches
for and locates the corresponding hardware address register, and then
begins a power-off sequence. In another example, when a motor is stopped,
the binary I/O module 722 may read the corresponding hardware address and
return a flag indicating that the particular motor has been stopped.

[0063]The universal control consol embodying features of the present
invention may be operated in regular ambient temperature and usually
requires no special sterilization. The operating voltage may be from 100
to 240 VAC with corresponding standard current limits. It also meets
other industry required environmental conditions such as the CISPR 11 or
IEC 60601-1-2:2001 for electromagnetic generation and IEC601-2-2 Section
44.3 for drip, splash and immersion requirement. It also meets various
international standards including various safety requirements for medical
equipments in different countries such as Japan, Canada, EU, and US.

[0064]FIG. 8 illustrates a design 1000 embodying the interaction between a
biopsy device 1002, as further illustrated in FIG. 9, and the universal
control consol 102 in accordance with one example of the present
disclosure.

General Design Specifications

[0065]In this embodying design 1000, the medical device such as a biopsy
device 1002 consists of the SenoCor DR3000 biopsy driver 1004 and a
surgical element such as the SenoCor 360 biopsy probe 1006. The biopsy
probe 1006 and biopsy driver 1004, when used in conjunction with the
universal control consol 102, a VS3000 vacuum system 1008 and a SenoRx
ES300 ESG module 1010, are designed to obtain breast tissue biopsy
samples. The specifications of SenoCor DR3000, SenoCor 360, VS3000 and
SenoRx ES300 may be found at SenoRx's website, at:
http://www.senorx.com/products/product_catalog/index.asp

[0066]With reference to FIGS. 3, 4 and 8, the universal control consol 102
is connected from the medical device connector 308, via a control cable
1012, to the biopsy driver 1004. When the biopsy device 1002 is connected
as shown in FIG. 8, the universal control consol 102 may provide user
interface, motor speed control, and operator feedback for the biopsy
driver 1004.

Design Features

[0067]The embodying design 1000 provides many features, four of which are
highlighted below:

[0068]1) Radiofrequency (RF) Cutting Tip

[0069]The biopsy probe 1006 that attaches to the biopsy driver 1004
incorporates a disposable RF cutting tip. The RF cutting tip enables the
device to slide easily through difficult heterogeneous breast tissue, and
to penetrate through dense lesions, thereby improving the targeting
capability of the device. RF energy is developed by the ESG module 1010,
which is controlled by a dual footswitch 1014 and the universal control
consol 102. The generator-enable signal is routed from the footswitch
1014 via a cable 1016 to the connector 406, and then through the ESG
connector 410 via a cable 1018 to a footswitch input connector on the ESG
module 1010. The cable 1018, which may be designed for RS-485
communication, provides a communication path to allow the universal
control consol 102 to configure the ESG module 1010 for the biopsy device
1002. The RF output from the ESG module 1010 is fed, via a RF cable 1024,
to a RF cable connector 1026 of the biopsy driver 1004. The patient
return pad 1028 is connected to the ESG module 1010 via a cable 1030.

[0070]2) Integrated Coaxial Probe

[0071]The disposable biopsy probe 1006 consists of an inner cutting trocar
and sample chamber with an outer probe. A trocar is a sharply pointed
surgical instrument fitted with a probe and used to insert the probe into
a body cavity, typically, as a drainage outlet. An outer probe is
typically a small tube for insertion into a body cavity. After a lesion
has been targeted, the outer probe remains in place while the inner
sample chamber is removed following the removal of a biopsy specimen. The
above functions are generated by DC motors in the biopsy driver 1004 that
provide linear or rotary motions for the disposable biopsy probe 1006.
Medical devices may contain up to four DC motors and each motor is driven
by a DAC output located in the universal control consol 102. These
signals and the other required signals are routed through the medical
device connector 308 and the control cable 1012 to the biopsy driver
1004.

[0072]3) Circumferential Vacuum Assisted Biopsy System

[0073]The device 1002 harvests tissue from a full 360-degree radius,
thereby enabling harvesting of tissue directly from the center of the
suspicious mass. This process is assisted by the use of the vacuum switch
located on the driver 1004 to remove any excess fluid from the biopsy
area. Vacuum is applied by the vacuum system 1008 to a vacuum tube
connector 1034 of the biopsy driver 1004 via a vacuum tube 1036. The
vacuum system 1008 is under the control of the universal control consol
102 via a cable 1038, which connects to the vacuum connector 408.

[0074]4) Control Buttons

[0075]With reference to FIG. 9, the biopsy device 1002 includes the biopsy
driver 1004 and the biopsy probe 1006, and incorporates three easy to use
push buttons: "sample", "vacuum", and "eject". To sample tissue, the
operator pushes the "sample" button 1102. To remove excess fluid from the
biopsy cavity, the operator pushes the "vacuum" button 1104. To change
probes for the next operation, the operator pushes certain functional key
or unlocking mechanism such as the "eject" button 1106, after which the
disposable probe is easily removed. There are two optical sensors to
determine probe size (e.g., diameter) and indicate to the system that the
disposable probe is in place or removed. It is understood by those
skilled in the art that the actions associated with the said buttons may
differ in different probe designs, dependent upon functional and software
control requirements.

Technical Specifications

[0076]Specifications for seven of many connectors, cables and tubes
associated with the universal control consol 102 are shown as follows:

[0077]1) The Medical Device Connector

[0078]With reference to FIGS. 3, 8 and 9, the connector 308 is a 56-pin
connector, with shielded cable and with non-isolated I/O. The inputs from
the medical device is preferred to have six digital wires (switches or
position sensors) as well as eight encoder wires (two signals lines per
encoder). The outputs to the medical device in this example contain four
wires for power (+12 VDC, -12 VDC, +5 VDC, ground), six digital wires for
LED indicators and relay controls, and eight wires for motor drive
control (two wires per motor). The medical device is preferred to have up
to 4 DC motors. For example, the universal control consol 102 may provide
12-bit DAC outputs for each motor. There is a maximum of 2 Amps for all
four motors. Each motor can draw up to 1 Amp, and maintain a 2 Amp-limit
on all four motors. In addition, eight wires are used for EEPROM
communication, two wires may be used for grounds (one for shield, the
other for connector case), and five spare wires are included for future
expansion. It is understood that various types of motors can be used by
different medical devices, and the universal control consol 102 can
implement appropriate connectors for controlling the medical device with
special requirement for the connector.

[0079]2) The Footswitch Connector

[0080]The connector 406 is a 12-pin connector, with shielded cable and
with isolated I/O. The footswitch may use two wires for the active
signals, one wire for the common return signal, one wire for a shielded
signal and eight spare wires for future expansion.

[0081]The ESG connector 410. The connector 410 is a 15-pin connector, with
shielded cable and with isolated I/O. The connector 410 may contain
inputs and output to and from the ESG module 1010 for communicating its
status or configuring the ESG module 1010 using a RS-485 communication
bus. The connector 410 may also contain several spare wires for future
expansion.

[0082]3) The Vacuum Connector

[0083]The connector 408 is an 18-pin connector, with shielded cable and
with isolated I/O. The connector uses two wires for vacuum system data
and clock. The inputs contain four bits for vacuum level plus two bits
for control. Also included are wires that carry power-on and vacuum-ready
status signals.

[0084]The external computer interface connector 414. The connector 414 is
a 14-pin connector, with non-shielded cable and with non-isolated I/O. It
contains 10 wires for BDM communication, three wires for RS-232
communication, and one wire for the shop mode switch that is in turn used
for system troubleshooting and/or upgrade.

[0085]4) The Input Power Connector

[0086]The connector 418 is a 3-pin connector, with a non-shielded,
removable cord. The input power may be 100/220 VAC, at 50 or 60 Hz, with
a 2 Amps maximum input limit.

[0087]5) The Output Power Connector

[0088]The connector 420 is a 3-pin connector, with a non-shielded,
removable cord. The output power may be 100/220 VAC, at 50 or 60 Hz.

[0089]6) Driver Components

[0090]The device 1002 has the following components that are controlled by
the software script downloaded into the universal control consol 102:

[0091]7) Stroke Motor

[0092]The stroke motor controls the axial motion of the cutting sleeve of
the device 1002. The motor is in turn controlled by the motor control
module 720.

[0093]8) Cutting Motor

[0094]The cutting motor controls the rotational motion of the cutting
sleeve of the device 1002. The motor is in turn controlled by the motor
control module 720.

[0095]9) Vacuum And Sample Switches

[0096]The vacuum and sample switches of the device 1002 are contact inputs
to digital inputs of the control module 102. The script uses the API as
specified in the API module 706 to retrieve the values of these inputs
from the control module 102.

[0097]10) Vacuum LED

[0098]The Vacuum LED of the device 1002 is an output of the control module
102. The script uses the API as specified in the API module 706 to
control its state.

[0099]The driver unit receives its power, control and status information
via the control cable 1012 that connects to the medical device connector
308 of the universal control consol 102. The device 1002 requires a
vacuum to remove any excess fluid in the biopsy area and to pull tissue
into the biopsy area for subsequent cutting. This vacuum is applied via
the vacuum connector 1034 and controlled by the "vacuum" button 1104 or
the script software depending on the state of the tool. Controlled RF
power or a mechanical cutter may also be necessary for the device 1002 to
cut through breast tissue. The RF power is applied through the RF cable
connector 1026 and controlled by the footswitch 1014. Also the script
software can inhibit the footswitch use or turn on the RF power without
the footswitch. Whenever a sample of the tissue is desired, the "sample"
button 1102 may be pressed to obtain the tissue sample.

[0100]There may be other components that are needed for the medical
operation. For example, sterile water or saline line is needed for
various surgical operations, and it can be provided through and
controlled by the control consol as well.

[0101]11) Flow Logic

[0102]FIG. 10A presents a flowchart 1200 covering the initial script
initialization, normal surgical operation states, failure states, and
tool exit states of the biopsy driver 1004 in operation with the
universal control consol 102 in accordance with one example of the
present disclosure. Display screens are generated on the graphical
display screen 304 of the universal control consol 102 based on the state
of the system. The system may display the status and user action
information of the universal control consol 102 and those of the medical
device to the operator via various display screens during a surgical
operation.

[0103]With reference to FIGS. 5, 6 and 10A, the display screens 602
through 616 cover from initial boot-up, medical device connection,
utility mode setup, boot-up alarm sequence to the downloading of the
medical device script. The specific states in FIG. 10A are unique to the
biopsy driver 1004 operating with the universal control consol 102 and
are depicted in FIG. 5 as the flow 502. Any other medical device attached
to the universal control consol 102 may have unique states and display
screens for their operation.

[0104]FIGS. 10B to 10D present various display screens in relation to
states in FIG. 10A in accordance with one example of the present
disclosure. With reference to FIGS. 10A to 10D, a script initialization
state 1202 may have a display screen that looks like the screen 1204. In
this state, initial system parameters, vacuum system parameters, and RF
generator parameters are set. This state is initiated after the medical
device script is downloaded to the universal control consol. If this
initialization is successful, the flow goes to a tool initialization
state 1206, whose display screen may look like the screen 1208 or the
screen 1210, if this is a subsequent initialization due to a reset. If
the vacuum initialization fails in the script initialization state, the
flow goes to a tool exit state 1212. If an error occurs, the script will
exit to the appropriate error state.

[0105]In the tool initialization state 1206, tools are initialized without
a probe inserted. The tool cycles the stroke motor, by ensuring that it
operates at the full stroke and is left in the closed position. On the
closing stroke the tool operates the cutting motor, thereby checking for
its function. The tool polls the probe's phototransistors to ensure that
a tool is not inserted. The tool polls the switches available to the user
("vacuum", "sample" and "foot switches") to ensure that none of them is
pressed at the end of the cycle of the stroke motor, a situation that may
indicate a stuck contact. If a probe is inserted during this state, the
software exits to the tool failure state and may display a display screen
1214. If an error further occurs, the script will exit to the appropriate
error state.

[0106]In the calibration state 1216, if the tool initialization state 1206
is successful, the screen 1218 is displayed while waiting for the
surgical component such as a probe or a blade to be inserted. Once the
probe is inserted, the calibration state 1216 first waits for the
"sample" button to be pressed by the operator and then performs two short
strokes to calibrate the tool, when the screen 1220 may be displayed. If
an error occurs during calibration, such as when the stroke motor is not
responding properly or the probe becomes unlatched, the script will exit
to a tool failure state 1222 and displays the screen 1224. If an error
further occurs, the script will exit to the appropriate error state.

[0107]If calibration is successful, the flow goes to a biopsy area closed
state 1226. The biopsy area closed state 1226 first waits for the
"sample" button to be pressed and then opens the cutter. In state 1226,
the script performs the following functions: [0108]1. Continually
monitor for vacuum and generator system failures; [0109]2. Continually
monitor for new foot switch and Sample switch presses; [0110]3. If a new
footswitch press is detected and the "sample" button is not pressed,
activate the RF Generator; [0111]4. If the "vacuum" button is pressed and
held for approximately one second, enable the distal trim and display the
distal trim enabled screen; [0112]5. If the "vacuum" button is pressed
while distal trim is enabled, disable distal trim; and [0113]6. If the
"sample" button is pressed and the footswitch is not pressed, go to the
opening biopsy area state 1238.

[0114]Some of the possible screens in the state 1226 are: screen 1228,
wherein the biopsy area is closed and RF is inactive; screen 1230,
wherein the biopsy area is closed but RF is active; screen 1232, wherein
the biopsy area is closed and RF is disabled; screen 1234, wherein distal
trim is enabled; and screen 1236, wherein the biopsy area is closed, RF
is inactive and the footswitch is still pressed from previous RF
activation.

[0115]The state 1226 typically goes to the state 1238 when the "sample"
button is pressed. In the state 1238, the script performs an open stroke
if the distal trim is not enabled and displays the screen 1240. It is
understood that the operator may select a full or half stroke opening of
a biopsy cutter, and some necessary GUI may be provided. When the open
stroke is successfully completed, the flow goes to the biopsy area open
state 1242. If an error occurs during the state 1238, such as when the
stroke motor is not responding properly or probe becomes unlatched, the
script will exit to the tool failure state 1222. If other errors further
occur, the script will exit to the appropriate error state.

[0116]In the state 1242, the operator is allowed to activate the vacuum
module or ESG module (e.g., if distal trim is not enabled). When the
"sample" switch is pressed, the flow typically goes to the closing biopsy
area state 1244. The ESG module is disabled if this state is entered from
the probe unlatched state PUS, where the probe became unlatched during
the close & cut processing of the state 1244.

[0117]In state 1242, the script performs the following functions:
[0118]1. RF is disabled if this state is entered from the state PUS,
where the probe becomes unlatched during the close & cut processing of
the closing biopsy area state. RF is also disabled if distal trim is
enabled; [0119]2. Continually monitor for failures from the vacuum and
ESG modules; [0120]3. Continually monitor for a new footswitch press, a
new "vacuum" button press and a new "sample" button press; [0121]4. If RF
is not disabled, a new footswitch press is detected and the "sample"
button is not pressed, activate the ESG module; [0122]5. If the "vacuum"
button is pressed and the "sample" button is not pressed, activate the
vacuum module; and [0123]6. If the "sample" button is pressed and the
footswitch is not pressed, go to the closing biopsy area state.

[0124]Some of the possible screens in the state 1242 are: the screen 1246,
which is displayed upon successful completion of the state 1238, or other
states defaulting to the state 1242 even as the state 1242 is not
explicitly listed; the screen 1248, which is displayed after fast-closing
processing failed but biopsy area is subsequently opened; the screen
1250, which is displayed after entering from the state 1238 after the
state 1244 and close and cut processing state have failed but biopsy area
is subsequently opened; the screen 1252, which is displayed after
entering from the completion of the state 1238 after the timer expired or
the stroke motor has stopped during the state 1238; the screen 1254,
which is displayed after entering from the state PUS, which is in turn
entered from the state 1244 during the close and cut processing state;
the screen 1256, which is displayed when ESG module is active; the screen
1258, which is displayed when the vacuum module is active; the screen
1260, which is displayed when entering from the successful completion of
the state 1238, or other entry points not explicitly listed; the screen
1262, which is entered from the state 1238 after the state 1244 and the
close and cut processing state have failed but biopsy area is
subsequently opened; the screen 1264, which is entered from the
completion of the state 1238 after the time expired or after the stroke
motor has stopped during the state 1238; and the screen 1266, which is
entered from the successful completion of the state 1238 when distal trim
is enabled.

[0125]In state 1244, the vacuum module is activated for two seconds, and
then the state 1244 starts the stroke motor to close the cutter and
starts the cutting motor. If the "vacuum" button is pressed during the
two-second vacuum period, the script will immediately start the stroke
motor, at a rate faster than used when cutting, and will not start the
cutting motor. When the close stroke is successfully completed, the flow
goes to the state 1226. If an error further occurs, the script will exit
to the appropriate error state.

[0126]In state 1244, the script performs the following operations:
[0127]1. If the distal trim is not enabled, turn on vacuum for 2 second
pre-vacuum period; [0128]2. If the "Sample" button is pressed during the
pre-vacuum period, start the stroke motor at a fast rate to just close
the cutter ("Fast Close"). If the Sample button was not pressed, or if
the distal trim is enabled, start the stroke motor to close the cutter
and start the cutting motor; [0129]3. If the Sample button is pressed
during a normal cutting operation (not a Fast Close), stop the motors,
keeping the vacuum on. When the Sample button is pressed again, start
both motors again; and [0130]4. After the cutter has closed, if the
distal trim is enabled, start the cutting motor in the opposite direction
for a brief period to perform the distal trim.

[0131]Some of the possible screens in the state 1244 are: the screen 1268,
which is displayed during pre-sample vacuum processing; the screen 1270,
which is displayed during fast-closing processing; the screen 1272, which
is displayed during close and cut processing; the screen 1274, which is
displayed during the pause sample processing; and the screen 1276, which
is displayed during distal trim processing. It is further understood that
if in any one of the states 1216, 1222, 1226, 1238, 1242, 1244, a medical
device such as the biopsy driver is removed, all these states are routed
to state 1212.

[0132]FIG. 11A presents a flowchart 1300 covering the unlatched probe
processing state of the biopsy driver 1004 in operation with the
universal control consol 102 in accordance with one example of the
present disclosure. When the probe is re-latched after being unlatched in
the state PUS, the flow goes to a state 1302, where the flow will stay
until the probe becomes unlatched, when the flow goes back to the state
PUS.

[0133]The state PUS is entered from any operational (non-error) state that
has a probe inserted in the device. The script prompts the user to reseat
the probe as is displayed to the operator as screen 1278. In most cases,
this state exits back to the state the script was in when the error
occurred. The exception is if the script was in the state 1244, in either
the pre-sample vacuum or close and cut processing. In those cases, the
state PUS exits to the state 1242, with the ESG module disabled if the
error occurred during the close and cut processing.

[0134]FIG. 11B presents a display screen in relation to the state PUS in
FIG. 10A in accordance with one example of the present disclosure. The
screen 1304 is displayed when the probe is unlatched, thereby requiring
the operator to reseat the probe and reset the device.

[0135]FIG. 12 presents various display screens in the tool failure state
1222 of the biopsy driver 1004 in operation with the universal control
consol 102 in accordance with one example of the present disclosure. The
tool failure state is an error state that is entered when an error occurs
that requires that the probe to be removed from the device. This state
displays a message indicating the error that has occurred and then waits
for probe to be removed. Various screens are displayed in the tool
failure state: the screen 1402, when a probe was inserted in the device
during the state 1206; the screen 1404, after a biopsy has failed and the
subsequent states 1238 also failed; and the screen 1406, after
calibration has failed and open stroke has failed to complete.

[0136]FIG. 13A presents a flowchart 1500 covering the ESG module failure
states (EMFS), whose display screens are further illustrated in FIG. 13B,
of the biopsy driver 1004 in operation with the universal control consol
102 in accordance with one example of the present disclosure. When the
ESG module failure is corrected after being triggered in the state EMFS,
the flow goes to a state 1502, where the flow will stay until the ESG
module failure is triggered again, when the flow goes back to the state
EMFS.

[0137]With reference to both FIGS. 13A and 13B, the state EMFS is entered
from any state, except the states 1202 and 1212, when the system detects
a failure in the system. The script supports two types of ESG modules and
the detection of a failure depends upon the ESG module type. The absence
of any ESG module connected causes an ESG module failure. In addition, if
a Type-C generator is detected, a failure is caused when it does not
respond or if the patient pad is not connected when required. (It is
required during calibration state and whenever ESG RF is activated.) The
following screens are displayed in the ESG module failure state: the
screen 1504, which is displayed when there is a patient pad failure; and
the screen 1506, which is displayed when there is an ESG module failure.

[0138]FIG. 14A presents a flowchart 1600 covering the vacuum failure
states (VFS), whose display screens are further illustrated in FIG. 14B,
of the biopsy driver 1004 in operation with the universal control consol
102 in accordance with one example of the present disclosure. When the
vacuum failure is corrected after being triggered in the state VFS, the
flow goes to a state 1602, where the flow will stay until the vacuum
failure is triggered again, when the flow goes back to the state VFS.

[0139]With reference to both FIGS. 14A and 14B, the state VFS is entered
from most states when the system detects a failure in the vacuum module.
The failure may be a result of the unavailability of the vacuum module
(it becomes disconnected) or of a vacuum level that does not meet the
minimum requirements. The script will wait for eight seconds to allow the
vacuum module to recover, and may turn off the vacuum module and require
the operator to press the "reset" button to continue.

[0140]The following screens are displayed in the vacuum failure state: the
screen 1604, which is displayed while the vacuum is recovering; the
screen 1606, which is displayed after the vacuum is not recovered; and
the screen 1608, which is displayed after vacuum has failed to recover.

[0141]FIG. 15A presents a flowchart 1700 covering the exit processing
states, whose display screens are further illustrated in FIG. 15B, of the
biopsy driver 1004 in operation with the universal control consol 102 in
accordance with one example of the present disclosure. When the driver is
removed from any state, the tool exit state TES is triggered. Typically,
if the time expires, or the ESG module is reconfigured, the flow goes
back to a prior menu screen. If the driver is reconnected, the flow goes
to the state 1206.

[0142]The following screens are displayed in the tool exit state: the
screen 1702, which is displayed after an integrity check for the ESG
module has failed; the screen 1704, which is displayed after an integrity
for the tool has failed; the screen 1706, which is displayed after the
pump fails to initialize; and the screen 1708, which is displayed after
the tool script exits normally.

[0143]The above disclosure provides many different embodiments or examples
for implementing different features of the disclosure. Specific examples
of components and processes are described to help clarify the disclosure.
These are, of course, merely examples and are not intended to limit the
disclosure from that described in the claims.

[0144]Although the invention is illustrated and described herein as
embodied in a design and method for a universal reusable medical
equipment control module, it is nevertheless not intended to be limited
to the details shown, since various modifications and structural changes
may be made therein without departing from the spirit of the invention
and within the scope and range of equivalents of the claims. Accordingly,
it is appropriate that the appended claims be construed broadly and in a
manner consistent with the scope of the disclosure, as set forth in the
following claims.